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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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MeltArray High Risk HPV Genotyping Assay

MeltArray High Risk HPV Genotyping Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703792
Basic UDI-DI: B-06956299703792
Reference: 801943
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP22)

Sanity-2 Respiratory Pathogen Panel (RPP22)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703716
Basic UDI-DI: B-06956299703716
Reference: 801949
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen Panel (RPP40D)

Respiratory Pathogen Panel (RPP40D)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703693
Basic UDI-DI: B-06956299703693
Reference: 801917
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Leukemia Fusion Genes (Q55) Screening Kit

Leukemia Fusion Genes (Q55) Screening Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703686
Basic UDI-DI: B-06956299703686
Reference: 803540
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Low Risk HPV Genotyping Kit (Sanity 2.0)

Low Risk HPV Genotyping Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703495
Basic UDI-DI: B-06956299703495
Reference: 801916
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP40)

Sanity-2 Respiratory Pathogen Panel (RPP40)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703488
Basic UDI-DI: B-06956299703488
Reference: 801918
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen Panel (RPP3D)

Respiratory Pathogen Panel (RPP3D)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703303
Basic UDI-DI: B-06956299703303
Reference: 801115
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP3)

Sanity-2 Respiratory Pathogen Panel (RPP3)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703297
Basic UDI-DI: B-06956299703297
Reference: 801114
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703280
Basic UDI-DI: B-06956299703280
Reference: 801406
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703273
Basic UDI-DI: B-06956299703273
Reference: 801306
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703266
Basic UDI-DI: B-06956299703266
Reference: 801305
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit

SARS-CoV-2 Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703259
Basic UDI-DI: B-06956299703259
Reference: 801304
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

CBFβ-MYH11 Detection Kit

CBFβ-MYH11 Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703235
Basic UDI-DI: B-06956299703235
Reference: 803320
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

WT1 Detection Kit

WT1 Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703228
Basic UDI-DI: B-06956299703228
Reference: 803319
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCR-ABL1 p210 Kit

BCR-ABL1 p210 Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703211
Basic UDI-DI: B-06956299703211
Reference: 803318
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCR-ABL1 p190 Kit

BCR-ABL1 p190 Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703204
Basic UDI-DI: B-06956299703204
Reference: 803317
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Leukemia Fusion Genes (Q51) Screening Kit

Leukemia Fusion Genes (Q51) Screening Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703198
Basic UDI-DI: B-06956299703198
Reference: 803100
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

PML-RARα Genotyping Kit

PML-RARα Genotyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703075
Basic UDI-DI: B-06956299703075
Reference: 803216
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCR-ABL1 Genotyping Kit

BCR-ABL1 Genotyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703068
Basic UDI-DI: B-06956299703068
Reference: 803215
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

PML-RARα S Detection Kit

PML-RARα S Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703044
Basic UDI-DI: B-06956299703044
Reference: 803213
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details